Global Regulatory Strategy Director

Exelixis Inc.; Alameda (CA); On-site; USD 301,000 - 380,000; Full time

Benefits offered by this job

401k plan with generous company-conrib

group medical, dental and vision

life and disability insurance

flexible spending accounts

discretionary annual bonus program

sales-based incentive plan

opportunity to purchase company stock

long-term incentives

15 accrued vacation days

17 paid holidays

up to 10 sick days

Job summary

Exelixis Inc. in Alameda, CA seeks an Executive Director of Regulatory Affairs to oversee global regulatory programs from pre-IND to post-approval. You will develop strategies across clinical, non-clinical and CMC areas, translate requirements into practical plans, and drive early approvals in phase 1–4 programs.

Lead the regulatory team and coordinate agency submissions with high-quality documentation. You will guide staff through INDs, NDAs, BLAs, and ensure timely agency interactions,

Qualifications

• Extensive regulatory leadership experience in pharma/biotech.
• Strong knowledge of FDA and international regulatory frameworks.
• Proven ability to translate complex regulations into actionable plans.
• Experience with oncology drug development is preferred.

Responsibilities

• Oversee Regulatory Program Leaders and staff.
• Develop regulatory strategies to maximize chances of registration.
• Maintain FDA relationships and ensure timely, compliant submissions.
• Lead cross-functional teams to prepare INDs/NDAs/BLAs and regulatory reports.
• Manage meetings with regulatory agencies and ensure high-quality documents.

Skills

Regulatory strategy

FDA interactions

Team leadership

Pharma oncology

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Job description

Exelixis Inc. in Alameda, CA seeks an Executive Director of Regulatory Affairs to oversee global regulatory programs from pre-IND to post-approval. You will develop strategies across clinical, non-clinical and CMC areas, translate requirements into practical plans, and drive early approvals in phase 1–4 programs.

Lead the regulatory team and coordinate agency submissions with high-quality documentation. You will guide staff through INDs, NDAs, BLAs, and ensure timely agency interactions,